NCT04007653

Brief Summary

The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Our aim of the study is to compare the long term outcomes along with the quality of life assessment of VTE in a group treated with heparin+VKA versus a group treated with heparin+edoxaban in the acute setting.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

July 1, 2019

Last Update Submit

July 2, 2019

Conditions

Venous Thromboembolic DiseasePost Thrombotic SyndromeChronic Thromboembolic Pulmonary HypertensionQuality of Life

Keywords

Post thrombotic syndromeEdoxabanVitamin K antagonistChronic Thromboembolic Pulmonary HypertensionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Post thrombotic syndrome (PTS)

    PTS according to Villalta

    up to 10 years

Secondary Outcomes (1)

  • Chronic thromboembolic pulmonary hypertension (CTEPH)

    up to 10 years

Study Arms (2)

Patients treated with heparin+edoxaban for VTE

Patients treated with heparin+edoxaban for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised.

Other: Observation

Patients treated with heparin+VKA for VTE

Patients treated with heparin+VKA for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised.

Other: Observation

Interventions

ObservationOTHER

No intervention

Patients treated with heparin+VKA for VTEPatients treated with heparin+edoxaban for VTE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were included in the HOKUSAI VTE trial for treatment of their DVT or PE.

You may qualify if:

  • Participant in the HOKUSAI VTE trial

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Postthrombotic Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Ingrid Bistervels, MD

CONTACT

+31205665976i.m.bistervels@amc.uva.nl

Roisin Bavalia, MD

CONTACT

0031 205667516r.bavalia@amc.uva.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

April 25, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

NL(1)